Status:
COMPLETED
A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes
Lead Sponsor:
Durrie Vision
Collaborating Sponsors:
Alcon Research
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to compare two post operative drop regimens for the management of dry eye and control of healing using FDA-approved ophthalmic solutions.
Detailed Description
This comparison will be made between bilateral eyes of the same patient following excimer laser ablation using the FDA-approved LADARVision 4000 Excimer Laser System or the WaveLight ALLEGRETTO WAVE™ ...
Eligibility Criteria
Inclusion
- Subjects must be a suitable candidate for FDA Approved LASIK.
- Subjects must have a stable refraction as documented by previous clinical records.
- Subjects who wear soft contact lenses must discontinue wear at least 3 days prior to preoperative exam or surgery.
- Subjects who wear gas permeable contact lenses must discontinue wear at least 3 weeks prior to preoperative exam or surgery.
- Subjects must be at least 18 years of age.
- Subjects must be willing and able to return for scheduled follow up examinations each day after surgery at the specified time.
- Subjects must sign and be given a copy of the written Informed Consent form.
Exclusion
- Subjects for whom either eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
- Subjects with clinically significant dry eye syndrome or clinically significant blepharitis in either eye.
- Subjects with clinically significant anterior segment pathology, including clinically significant cataracts, corneal scarring or neovascularization in either eye.
- Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
- Subjects who have a history of Herpes zoster or Herpes simplex keratitis.
- Subjects on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing, any immunocompromised subjects, and subjects with clinically significant atopic disease, connective tissue disease, or uncontrolled diabetes.
- Subjects with a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP\>25 mm Hg in either eye.
- Subjects with macular pathology in either eye.
- Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
- Subjects with known sensitivity to planned study concomitant medications.
- Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
- Use of ocular drugs, other than study medications, during the study and within 30 days prior to study entry or any other ocular medication.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00781092
Start Date
October 1 2008
End Date
March 1 2009
Last Update
September 20 2012
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.